Ascletis Pharma announces the Investigational New Drug (IND) application approval of ASC22 (Envafolimab) by U.S. Food and Drug Administration (FDA) for the indication of immune restoration/functional cure of human immunodeficiency virus 1 (HIV-1) infected patients.

ASC22 (Envafolimab) is a subcutaneously administered single-domain antibody against PD-L1 and has the potential to restore virus-specific immune responses in patients with chronic viral infection. Immune restoration/functional cure in HIV-1 infected patients is the second indication of ASC22 that obtained IND approval from U.S. FDA, in addition to the indication of functional cure of chronic hepatitis B (CHB) patients.

The U.S. FDA approved ASC22 trial is a multi-center, randomized, single-blind, placebo-controlled, Phase I/II clinical trial to evaluate the safety, efficacy, and pharmacokinetics characteristics of ASC22 in HIV infected patients on antiretroviral therapy (ART). The objectives of this Phase I/II trial are (1) to evaluate the safety of ASC22 versus placebo in participants on suppressive ART; (2) to determine whether ASC22 1.0 mg/kg, given once every four weeks, can improve HIV-1-specific cellular immune responses; and (3) to evaluate the effects of ASC22 versus placebo on latency reversal of HIV.

Ascletis announced that it had obtained a global and exclusive license as of November 8, 2021 from Suzhou Alphamab Co., Ltd. to develop and commercialize ASC22 for all viral diseases including Hepatitis B and HIV/AIDS. Ascletis books sales globally for ASC22 of all viral diseases.

"U.S. IND approval of ASC22 (Envafolimab) for HIV/AIDS treatment is a major step in our effort to pursue HIV functional cure. Meanwhile, we are looking forward to collaborating with the industrial leaders in the field of HIV/AIDS." said Jinzi J. Wu, PhD, Founder, Chairman and CEO of Ascletis.